PHACS has four active protocols: SMARTT, AMP, AMP Up, and AMP Up Lite. See below for a full description of each. To learn more or to request a fully copy of any protocol, please see the protocol description below.
SMARTT follows three cohorts of HIV- and ART-exposed but uninfected children: the Static, Dynamic, and Young Adult Surveillance cohorts. Enrollment into the Static cohort, which includes children less than 12 years of age at entry, closed with a final cohort of 1,240 subjects. Enrollment into the Dynamic cohort will remain open for an indefinite period, with the goal of enrolling up to 400 HIV-exposed but uninfected newborns per year. Please see the “Annual Administrative Report”, located in the “Study Documents” section, for the most up-to-date dynamic cohort enrollment numbers. PHACS will study both cohorts to estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born to HIV-infected mothers (source population). Occurrences of abnormalities from ART exposure in utero and/or in the first two months of life will be sought in multiple domains, including metabolic and growth, cardiac, neurological, neurodevelopmental, behavior, language, and hearing domains. The SMARTT domain-specific objectives are to:
- Metabolic Function and Growth
Estimate the occurrence of abnormal signals of somatic growth and body composition.
Estimate the occurrence of abnormal signals in measures of organ function, including the liver, muscles, and pancreas.
Evaluate other toxin exposures (e.g., licit and illicit drug exposure in utero or other toxins such as lead after birth) that may be alternative explanations for abnormal signals.
- Cardiac Function
Identify abnormalities in cardiac function related to ART and/or HIV exposure and to examine the utility of serum biomarkers as surrogate markers of cardiac dysfunction .
- Neurologic, Neurodevelopmental, Behavior, Language, and Hearing
Identify age-specific signals of neurological, neurodevelopmental, linguistic, social, and behavioral dysfunction.
Identify other neurologic conditions such as microcephaly, stroke, and febrile and non-febrile seizures.
Identify adverse signals of hearing dysfunction.
- Other Domains of Interest
Identify diagnoses and conditions of interest including but not limited to birth defects, unexplained death, and abnormalities of the hematopoeitic system.
To request a copy of the full SMARTT protocol, please email The PHACS Coordinating Center.
The Adolescent Master Protocol (AMP) includes children ages 7 years until their 16th birthday born to HIV-infected mothers. Enrollment is now closed with the perinatally exposed HIV-infected cohort enrolling a total of 451 children and the comparison group, consisting of perinatally exposed HIV-uninfected children, enrolling a final cohort of 227 children. This study is designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation; metabolic risk factors for cardiovascular disease; cardiac function; bone health; neurologic, neurodevelopment, language, hearing, and behavioral function; and adolescent gynecology and HPV infection. The AMP domain-specific objectives are to:
- Growth and sexual maturation
Longitudinally track growth and sexual maturation and the factors that influence growth and maturation.
- Metabolic risk factors for cardiovascular disease
Characterize the emergence of abnormal glucose metabolism, lipid abnormalities, body composition and other risk factors for cardiovascular disease and identify the contributing influences.
- Cardiac function
Estimate the prevalence of cardiac structural and functional abnormalities in HIV-infected children and youth.
- Bone mineral density
Estimate the differences in bone mineral density of HIV-infected children when compared to HIV-exposed but uninfected children and to identify factors contributing to abnormal bone mineralization.
- Neurologic, neurodevelopment, language, and behavioral function
Examine cognitive and behavioral outcomes of HIV-infected subjects, including high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use, neurodevelopmental impairment, school achievement and to compare them with an HIV-exposed but uninfected control cohort.
Examine non-adherence to antiretroviral therapy and predictors of non-adherence among HIV-infected children receiving ART.
Examine family and psychosocial factors associated with emotional and behavioral problems.
- Adolescent gynecology and HPV infection
Evaluate the occurrence and clinical course of cervical HPV infections and cervical abnormalities in perinatally HIV-infected and HIV-exposed but uninfected sexually active females who are having gynecologic exams performed as standard of care.
To request a copy of the full AMP protocol, please email The PHACS Coordinating Center.
The Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up) is enrolling young adults ages 18 and older who are born to HIV-infected mothers. Enrollment is ongoing, with the goal of enrolling up to 600 perinatally HIV-infected (PHIV+) and 250 perinatally HIV-exposed but uninfected (PHEU) young adults. Eligible individuals are those previously enrolled in AMP or SMARTT protocols as well as other perinatally-infected individuals. This study is designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. Data is being collected with a combination of online surveys, clinical assessments, interviews, and chart abstraction. The domain-specific AMP Up specific objectives are to:
- Infectious and Non-Infectious Complications of HIV and Its Treatment
Define the immunologic and virologic course of perinatal HIV infection, as well as its long-term effects on clinical outcomes, as youth age into adulthood.
- Metabolic Complications
To study the effects of HIV and antiretroviral medications on nutrition, metabolism and overall cardiometabolic risk in HIV-infected and HIV-exposed but uninfected young adults over time.
- Sexually Transmitted Infections
Evaluate access to testing and treatment for genital STIs, and the incidence of and risk factors for acquiring these STIs.
- Reproductive Health
Examine reproductive health outcomes including pregnancy, and determine the incidence and risk factors for maternal-to-child transmission of HIV.
- Neurocognitive Functioning and Mental Health
Examine the short- and long-term consequences of exposure to or infection with HIV and its treatment on cognition, academic achievement, and on the neurological, emotional, and behavioral development of young adults over time.
- Health Care Behaviors and Transition to Adult Health Care
Describe predictors of adherence to ART and health care in perinatally HIV-infected young adults and the transition into adult health care.
- Risk Behaviors
Examine the prevalence and predictors of sexual behaviors and use of licit and illicit substances in perintally HIV-infected and exposed, uninfected young adults.
- Transition to Adult Functioning
Identify factors associated with successful transition to adult functioning and quality of life.
- Hearing and Language
Estimate the prevalence of language and hearing impairment in young adults, and their impact on educational attainment, psychosocial, and cognitive function, and employment outcomes.
To request a copy of the full AMP Up protocol, please email The PHACS Coordinating Center.
In 2017, a “Lite” version of AMP Up was created that shares similar objectives with AMP Up but with less intensive data collection. AMP Up Lite enrolls perinatally HIV-infected young adults. In addition to opening at established PHACS sites, this study recruits from clinics and areas in the U.S. where AMP Up did not open to enrollment.